EU Regulation 10/2011: plastics in contact with food
You've chosen a food-grade technopolymer for a gear in a food-contact zone. But is the material really compliant? And is material compliance enough, or is something else needed? EU Reg. 10/2011 answers these questions precisely: it establishes which materials are permitted, how to demonstrate it and who is responsible for what.
Scope of application
EU Regulation 10/2011, and its subsequent amendments, sets the requirements for plastic materials and articles intended for contact with food. It applies to any component that may come into direct or indirect contact with food products during production, packaging, storage or transport.
For mechanical transmissions in the food industry, this includes gears, toothed wheels, guides, racks and any moving element in the food-contact zone or splash zone (the zone of possible contact with food splashes or vapors).
The positive list
The principle the regulation is based on is the positive list: only the monomers, additives and other process agents explicitly listed in Annex I, with their respective limits, are permitted for food contact. Any substance not on the list cannot be used.
This means it isn't enough for the finished material to be chemically inert. Every component of the formulation (base monomer, plasticizers, thermal stabilizers, internal lubricants, colorants, fillers) must appear in the positive list with the limits respected.
| Material | EU Reg. 10/2011 compliance | Notes for transmission components |
|---|---|---|
| Natural POM-C (white) | Yes (specific formulations) | Verify the manufacturer's compliance sheet |
| Black or colored POM-C | Case by case | The colorants must be on the positive list |
| Natural PA6 | Yes (specific formulations) | Verify the manufacturer's compliance sheet |
| Natural PA12 | Yes (specific formulations) | Verify the manufacturer's compliance sheet |
| Natural polyketone (PK) | Yes (specific formulations) | Excellent chemical and thermal resistance |
| Natural PEEK | Yes | Costly but maximum thermal resistance |
| PA6 + glass fiber | Case by case | The fillers must be on the positive list |
| POM-C + graphite or MoS₂ | Not suitable for food | Graphite and MoS₂ aren't on the positive list |
Migration limits
The regulation defines two categories of limits. The Overall Migration Limit (OML) sets the maximum total quantity of substances that can transfer to the food: generally 10 mg/dm² or 60 mg/kg of food. The Specific Migration Limits (SML) set instead individual thresholds for the most critical substances.
Migration tests are carried out with standardized food simulants: water, 3% acetic acid, 10% or 20% ethanol, olive oil. Temperature and duration of the test vary as a function of the type of contact foreseen.
Declaration of Conformity (DoC)
For every plastic component in food contact, the supplier is obliged to issue a Declaration of Conformity (DoC) pursuant to art. 15 of EU Reg. 10/2011. The DoC must indicate: standards applied, name and address of the supplier, identification of the material, usage limitations (temperature, type of food, contact time) and available test data.
The DoC must refer to the finished product in its specific formulation, not to the base material. A POM-C gear with an internal lubricant isn't covered by the DoC of natural POM-C.
Compliance doesn't mean automatic suitability
A material compliant with EU Reg. 10/2011 is authorized for food-contact use, but doesn't guarantee suitability for any specific application. The machine manufacturer is responsible for verifying that the migration under the real conditions of use doesn't exceed the permitted limits.
For critical applications, such as direct contact with hot, acidic or fatty liquid foods, request from the material supplier the migration test data under the foreseen operating conditions, not just the generic declaration of conformity.
If you're designing a transmission for a food-contact application and have doubts about the material's compliance or the necessary documentation, write to the technical office. We verify the component's DoC and the conditions of use together.